Pregnancy Outcomes of Patients Having NC-FET Regarding th... | NCT05690360

Studies
Pregnancy Outcomes of Patients Having NC-FET Regarding the Progesterone Levels

NCT05690360

Sponsor

Acibadem University

Status

Unknown status

Last Update Posted

Jan 19, 2023Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2022Actual

Primary Completion Date

Apr 15, 2023Estimated

Completion Date

Aug 15, 2023Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 19, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nazli Albayrak, Resident in training at Acibadem University, School of Medicine, Department of Obstetrics and Gynecology, Acibadem UniversityPrincipal Investigator

Lead Sponsor

Acibadem UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cummulative Live Birth Rate	Live birth rates of Patient with NC-FET followed up with progesterone levels	10 months
Biochemical pregnancy results	Biochemical pregnancy results of patients with NC-FET followed up with progesterone levels	2 months
Pregnancy complications	Obstetric Complications of Patient with NC-FET followed up with progesterone levels	10 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with regular menstrual cycle
patients aged btw 20-40
patients with pregnancy with NC-FET by using the progesterone for the detection of ovulation

Exclusion Criteria:

Spontenous pregnancies
Multiple pregnancies

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Participants are going to be selected from the patients who applied to infertility clinic, and are pregnant with in vitro fertilization natural cycle- frozen embryo transfer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Turgut Aydin, MD	Contact	00905323722713		turgut.aydin@acibadem.com
Nazli Albayrak, MD	Contact	00905054111626		albayraknazli@gmail.com

Overall Officials

Name	Affiliation	Role
NAZLI ALBAYRAK, MD	Acıbadem University School of Medicine	Principal Investigator
TURGUT AYDIN, MD	Acıbadem University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Acibadem University Atakent Hospital	Recruiting	Istanbul		34303	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided